Tuesday 16 August 2011

FDA Regulations and E-cigarettes

By Gareth Jale


The FDA recently reported to the stakeholders that it was planning to bring changes in rules for treating electronic cigarettes in the same manner as tobacco-based cigarettes were being treated. With this electronic cigarette makers and distributors have literally won a temporary battle against the FDA. E-cigarettes are basically metal and plastic devices containing nicotine solution in a cartridge. The solution (called E-juice) is heated by e-cigarette atomizers in order to create vapors to be inhaled by the smoker. And, there is a light at the end of the e-cig that makes it resemble a real cigarette.

As per users and manufacturers, ecigarettes address two aspects of traditional cigarettes. The first is the nicotine addiction and the second is the behavioral facets of smoking. The behavioral aspects of smoking include holding of the cigarette, puffing, viewing the smoke and the movement of hand. All without the over 4,000 chemicals that the traditional cigarette has. E-cigarettes were first sold overseas, and it was not until 2006 that they were allowed to be used in the U.S.. With a user base growing at more than tens of thousands every week, there are more than millions of e-cig smokers globally.

Some of the electronic cigarette manufacturers have been claiming that these cigarettes can help users quit smoking traditional cigarettes. As per the Centers for Disease Control and Prevention, more than 46 million people smoke in the U.S., and around 40% every year are trying to quit smoking. But, compared to nicotine patches and gums, e-cigarettes have been in use in the legal gray area. Last year, a case was lost by the FDA where it wanted to treat e-cigs as devices for drug-delivery and not as tobacco products. However, the court adjudged e-cigs to be regulated as tobacco products.

The FDA found the introduction of e-cigarettes to be a chance to extend their regulatory authority. However, it was not more than a decade ago when it had lost to regulate smokeless cigarettes and tobacco. But, then the FDA started using other methods to regulate e-cigs.

In 2009, the FDA started claiming that e-cigarettes can increase nicotine addiction and tobacco use in the young and many shipments were confined by it. The FDA then claimed that the product fell under the definition of the Act, which was challenged by the makers. But, the D.C. Court of Appeals in 2010 confirmed an earlier court decision that FDA couldn't regulate e-cigs as devices or drugs under the Act. And, the court only held that the FDA could only regulate e-cigarette marketing as per the Tobacco Act.




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